Competence and Training
Completing training is useful, but the purpose is to help people perform their assigned work correctly. A quality management system needs evidence of competence appropriate to the activity.
This lesson starts with the work itself. Watch how the task defines the competence needed, how gaps lead to training or other action, and how an evaluation checks whether that action worked. A course can build understanding, while practical duties may require additional evidence.
Begin with the task
Competence combines suitable education, training, skills, and experience for the assigned activity. Begin by defining what a person must know and be able to do.
Then compare those needs with the evidence already available. An experienced technician may know a measurement method but still need instruction on your equipment, procedure, or product.
A course title or years of employment can be relevant evidence. Neither establishes competence for every task. The important connection is between the person's abilities and the work they will actually perform.
Find the actual gap
Before choosing more training, understand the gap. Is the person missing information, practical skill, familiarity with equipment, or experience applying the procedure?
Imagine an operator who can explain the written acceptance criteria but cannot obtain reliable measurements. Sending the same reading again may not address the difficulty.
Define what successful performance should look like. This gives both the learner and the evaluator a clear basis for choosing the action and later checking its result. A specific gap is easier to address than a general instruction to get more training.
Choose an action that fits
Training is one way to address a competence gap. Supervised practice, mentoring, additional education, or assigning the activity to someone already competent may also be appropriate.
Choose an action that addresses the actual need. Someone learning a measurement technique may benefit from demonstration and practice. Someone unfamiliar with a revised instruction may need focused explanation of the change.
Agree on the expected result before the action begins. That keeps the effort connected to the work rather than treating attendance or a completed reading assignment as the entire objective.
Evaluate knowledge and execution
Select an evaluation proportionate to the risk of the work. A quiz can check understanding. Observation or a work sample can check whether the person can perform the task.
A higher-risk product test may need a witnessed demonstration and review of actual records. The evaluation should fit what could go wrong and what evidence is needed to support the assignment.
Record what was evaluated and the result. Opening a video, attending a session, or checking an attestation box provides limited evidence. Those activities alone do not show that someone can safely perform independent work.
Understand what a course result means
In this course, an eighty-percent quiz target is a company benchmark. It is not a percentage mandated by ISO or FDA.
A passing result provides evidence about the understanding assessed by the quiz. It does not automatically establish practical skill or authorize every quality-related duty.
If a person passes a knowledge assessment but struggles with the actual task, the practical result identifies a remaining gap. Address that gap rather than treating the earlier score as proof that further evaluation is unnecessary.
Keep a useful training record
Retain appropriate evidence of education, training, skills, and experience. A useful training record connects the person and task with the assigned material and revision, date, evaluation method, result, and evaluator.
Record missed topics and follow-up honestly. The record should help another person understand what was covered and what the evidence actually supports.
An entry that simply says trained may not answer those questions. A record tied to the specific activity helps distinguish a foundation course, instruction on an approved procedure, and a successful practical demonstration.
Competence needs maintenance
Work changes over time. Revisit training needs when procedures, equipment, responsibilities, or applicable requirements change. Performance problems can also reveal a competence gap.
The question is what the change means for the person's assigned activity. It may call for targeted instruction, further practice, or a different effectiveness check.
People should also understand how their work affects product quality and the quality objectives. Knowing why an activity matters can help connect an individual task to the performance of the wider quality management system.
From foundation course to assigned work
Consider a new technician learning incoming inspection. This foundation course introduces useful concepts. The technician then learns the approved inspection procedure and practices the actual task under supervision.
An evaluator checks the relevant performance and records the result. The supervisor records the evidence and scope of authorization under the company's controls.
If part of the task still needs improvement, that need remains visible. This approach makes the course one useful step in developing competence, with practical evidence supporting the duties the person is assigned.
What to carry into your work
Start with what the work requires. Use available evidence to identify gaps, choose actions that fit those gaps, and check whether the person can perform as needed. Keep the record specific enough to support that conclusion.
This lesson draws on the AAMI and ISO practical guide to ISO 13485, section six point two. It is introductory education, not authorization for independent duties. Applicable requirements and your company's approved procedures govern actual work.
SOURCE CREDIT AAMI/ISO 13485:2016 — Medical Devices: A Practical Guide (ISO 2017), §6.2; purchased through ANSI. This video presents original educational explanations informed by the guide. It is not an official AAMI, ISO, ANSI or FDA course. Applicable requirements and company procedures govern actual work.